The present disclosure relates generally to medical devices, systems, and methods. More specifically, the present disclosure relates to medical devices, systems, and methods for phototherapy to treat disorders such as hyperbilirubinemia and jaundice in infants.
Phototherapy typically involves shining light onto a patient's skin and is a promising clinical tool for the treatment of many conditions including affective disorder, sleep disorders, and skin disorders such as herpes, psoriasis, acne, and even skin cancer. Phototherapy is particularly promising in the treatment of neonatal hyperbilirubinemia, also known as newborn jaundice.
Neonatal hyperbilirubinemia affects over 60% of newborns worldwide. Hyperbilirubinemia is caused by the accumulation of excess bilirubin in the blood, which can give the skin and sclera of the eye a characteristic yellow color. If left untreated, an infant with severe jaundice may sustain neurological damage or even die. The condition requires treatment in approximately 12% of all infants. Studies have estimated that over 6 million newborns with severe jaundice are not receiving adequate treatment.
Hyperbilirubinemia can be treated using phototherapy. In such phototherapy, an infant is exposed to light in a wavelength range corresponding to the peak absorption spectra for bilirubin (blue-green, 400 to 520 nm), Absorption of the light leads to the conformational and structural isomerization of bilirubin into soluble forms that can be easily eliminated through urine.
The effectiveness of such phototherapeutic treatment is contingent on several factors. These factors include the intensity and spectrum of the delivered light, the surface area coverage of the delivered light, and the duration of light delivery. Existing devices are typically expensive, difficult to maintain, and often ineffective in low-income countries where the unmet need for jaundice treatment is the greatest. Thus, there is a need for high-performance phototherapy devices that are designed for extreme affordability. Also, illumination sources such as fluorescent bulbs, incandescent bulbs, fiber optic emitters, and LEDs are typically found in conventional phototherapy devices. Many of these illumination sources are not optimized for intensity, surface area coverage, maintenance, and costs.
The following literature publications may be of interest: “Light-Emitting Diodes: A Novel Light Source for Phototherapy” by Vreman et al, (1998), “An Evaluation of the Characteristics and Performance of Neonatal Phototherapy Equipment” by Dicken et al. (2000), “Treatment of Jaundice in Low Birthweight Infants” by Maisels et al. (2003), “A Prospective Randomized Controlled Study of Phototherapy Using Blue and Blue-Green Light-Emitting Devices, and Conventional Halogen-Quartz Phototherapy” by Seidman et al. (2003), and “Phototherapy: Current Methods and Future Directions” by Vreman et al. (2004).
The following patents and patent publications may be of interest: PCT Publication Nos. WO2008/011885 and WO2009/050213; U.S. Patent Application Publication Nos. 2006/0089685, 2006/0100675, 2006/0217787, 2006/0278816, 2006/0293727, 2007/0032842, 2007/0208395, 2007/0208397, 2007/0239232, 2008/0116401, 2008/0205033, 2008/0275533, 2009/0030490, 2009/0068613, 2010/0179469, 2012/0078328, 2012/0104277, and 2012/0280114; and, U.S. Pat. Nos. D639751, 3,877,437, 4,802,066, 5,339,223, 5,400,425, 5,698,866, 5,792,214, 6,045.575, 6,290,713, 6,402,681, 6,443,978, 6,464,714, 6,464,715, 6,596,016, 6,811,563, 6,866,678, 6,872,220, 6,955,684, 7,128,442, 7,131,990, 7,147,653, 7,210,817, 7,304,201, 7,305,163, 7,479,664, 8,026,528, 8,043,349, 8,048,136, 8,069,857, 8,202,307, 8,246,666, 8,267,922, 8,337,538, and 8,372,063.